Tag: Business

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Business

AM Best comments on credit ratings of Economical Mutual Insurance Company following announcement of demutualization vote

OLDWICK, N.J. — (BUSINESS WIRE) — #insurance—AM Best has commented that the Financial Strength Rating of A- (Excellent) and the Long-Term Issuer Credit Rating (Long-Term ICR) of “a-” (Excellent) of Economical Mutual Insurance Company (EMIC) (Waterloo, Ontario, Canada) remain unchanged following the company’s recently conducted vote on demutualization.

On May 20, 2021, EMIC called its third and final special meeting on its demutualization. The vote was nearly unanimous, carrying the approval of 97% of eligible voters. This approval will advance the company’s well-established plan to convert from a mutual company to a publicly traded share company through an anticipated initial public offering. The company has not made official the timing of the demutualization and subsequent IPO, as it will rely on market conditions, governmental approvals, company performance and other relevant factors.

AM Best notes that the demutualization has been a longstanding piece of the company’s strategic plan, and has proceeded in accordance with the management team’s expectations, albeit at a decelerated pace given the novelty of the process to regulators and COVID-19-related delays.

This press release relates to Credit Ratings that have been published on AM Best’s website. For all rating information relating to the release and pertinent disclosures, including details of the office responsible for issuing each of the individual ratings referenced in this release, please see AM Best’s Recent Rating Activity web page. For additional information regarding the use and limitations of Credit Rating opinions, please view Guide to Best’s Credit Ratings. For information on the proper media use of Best’s Credit Ratings and AM Best press releases, please view Guide for Media – Proper Use of Best’s Credit Ratings and AM Best Rating Action Press Releases.

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

Copyright © 2021 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Brian Lynch

Financial Analyst
+1 908 439 2200, ext. 5279
brian.lynch@ambest.com

Christopher Sharkey
Manager, Public Relations
+1 908 439 2200, ext. 5159
christopher.sharkey@ambest.com

Raymond Thomson, CPCU, ARe, ARM
Associate Director
+1 908 439 2200, ext. 5621
raymond.thomson@ambest.com

Jim Peavy
Director, Communications
+1 908 439 2200, ext. 5644

james.peavy@ambest.com

Categories
Local News Science

UroGen Pharma announces inducement grant under Nasdaq listing Rule 5635(c)(4)

PRINCETON, N.J. — (BUSINESS WIRE) — UroGen Pharma Ltd. (Nasdaq: URGN) a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced the grants of inducement restricted stock units (“RSUs”) to eleven new employees in connection with their employment with UroGen. These new team members will support the ongoing commercial launch of Jelmyto® (mitomycin) for pyelocalyceal solution, UroGen’s first approved product, and the continued development of the Company’s pipeline.

Up to 46,100 shares of UroGen’s common stock are issuable upon the vesting and settlement of the RSUs. The RSUs will vest equally over three years, with one third of the underlying shares vesting each year on the anniversary of the vesting date, subject in each case to the employee’s continued service relationship with UroGen.

The RSUs are subject to the terms and conditions of UroGen’s 2019 Inducement Plan and RSU grant notice and agreement thereunder. The RSU grants were granted as an inducement material to each employee entering into employment with UroGen in accordance with Nasdaq listing Rule 5635(c)(4).

About UroGen Pharma Ltd.

UroGen is a biopharmaceutical company dedicated to building novel solutions that treat specialty cancers and urologic diseases because patients deserve better options. UroGen has developed RTGelTM reverse-thermal hydrogel, a proprietary sustained release, hydrogel-based platform technology that has the potential to improve therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. UroGen’s first commercial product, and investigational treatment UGN-102 (mitomycin) for intravesical solution for patients with low-grade non-muscle invasive bladder cancer, are designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, New Jersey with operations in Israel. Visit www.urogen.com to learn more or follow us on Twitter, @UroGenPharma.

Contacts

INVESTOR CONTACTS:
Sara Blum Sherman

Head of Investor Relations

investors@urogen.com

Lee Roth

lroth@burnsmc.com
212-213-0006

MEDIA CONTACT:

Eric Van Zanten

Head of Communications

Eric.VanZanten@urogen.com
610-529-6219

Categories
Business Science

Patritumab Deruxtecan data at ASCO demonstrates tumor response across multiple resistance mechanisms in patients with advanced EGFR-mutated NSCLC

  • Oral presentation highlighting extended follow-up data from phase 1 study in patients with locally advanced or metastatic TKI-resistant, EGFR-mutated NSCLC shows promising clinical activity
  • Data from this study informed the design of the recently initiated pivotal HERTHENA-Lung01 trial in similar patient population

 

TOKYO, MUNICH & BASKING RIDGE, N.J. — (BUSINESS WIRE) — New data from Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo’s) patritumab deruxtecan (HER3-DXd), a HER3 directed antibody drug conjugate (ADC), demonstrated preliminary evidence of clinically meaningful and durable tumor response in patients with locally advanced or metastatic TKI-resistant, EGFR-mutated non-small cell lung cancer (NSCLC).

These extended follow-up data from the dose escalation portion and one expansion cohort of a phase 1 study of patritumab deruxtecan were presented today during an oral presentation (Abstract #9007) at the 2021 American Society of Clinical Oncology (#ASCO21) Virtual Scientific Program.

While the efficacy of targeted therapy with EGFR TKIs is well-established in the treatment of patients with advanced EGFR-mutated NSCLC, the development of a broad range of resistance mechanisms commonly leads to disease progression.1,2 Subsequent salvage therapies after EGFR TKI and platinum-based chemotherapy have limited efficacy with progression-free survival (PFS) of approximately 2.8 to 3.2 months.2 New treatment approaches are needed to overcome resistance and improve survival in these patients.

An objective response rate (ORR), as assessed by blinded central review, was 39% (CI 95%; 26-52%) in 57 evaluable patients treated with patritumab deruxtecan (5.6 mg/kg). One confirmed complete response and 21 partial responses were observed. The disease control rate was 72% (CI 95%; 59-83%). After a median follow-up of 10.2 months (range, 5.2-19.9 months), the estimated median duration of response was 6.9 months (CI 95%; range, 3.1-NE months) and the estimated median PFS was 8.2 months (CI 95%; range, 4.4-8.3 months). Confirmed responses were observed in patients across a spectrum of baseline tumor HER3 membrane expression levels, EGFR activating mutations and EGFR TKI resistance mechanisms, including EGFR activating mutations (Ex19del, L858R, G719Y), other EGFR mutations (T790M, C797S, Ex20ins), amplifications (EGFR, CCNE1, MET) and non-EGFR mutations and fusions (MET, KRAS). A subgroup of patients treated with osimertinib and platinum-based chemotherapy (n=44) prior to enrollment in the study demonstrated similar efficacy. An ORR of 39% (CI 95%; 24-55%) and PFS of 8.2 months (CI 95%; 4.0-NE) was observed in this subgroup. Additionally, the confirmed ORR and median PFS were similar in patients with or without a history of brain metastases.

“EGFR TKIs are the standard of care for patients with advanced EGFR-mutated NSCLC. However, the activity of these agents is limited by the development of acquired resistance mechanisms,” said Pasi A. Jänne, MD, PhD, Director, Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute. “In this study, where patients were heavily pre-treated, efficacy was observed in patients with and without known EGFR TKI resistance mechanisms in a population that is often difficult to treat. Targeting HER3 with patritumab deruxtecan may be a novel and promising strategy, and we look forward to further evaluating clinical activity and safety in the pivotal HERTHENA-Lung01 trial.”

The safety profile of patritumab deruxtecan in patients treated with the 5.6 mg/kg dose (n=57) is consistent with that seen across all patients (n=81) in both the dose escalation and dose expansion cohort 1 of the study (doses range from 3.2 to 6.4 mg/kg). Grade 3 or higher treatment emergent events (TEAEs) occurred in 64% of all patients (n=81). TEAEs grade 3 or higher severity occurring in ≥ 5% of all patients were platelet count decreased, neutrophil count decreased, fatigue, anemia, dyspnea, febrile neutropenia, hypoxia, white blood cell count decreased, hypokalemia and lymphocyte count decreased. There were four cases of treatment-related interstitial lung disease (ILD) reported, as determined by an independent adjudication committee, including two of grade 1 severity, one grade 2, and one grade 3. The median time to adjudicated onset of treatment-related ILD was 53 days (range, 13-130 days). There were five TEAEs associated with death including two cases of disease progression, two cases of respiratory failure and one case of shock. All TEAEs associated with death were considered not related to the study drug.

“Treatment options that provide meaningful therapeutic benefit for patients with EGFR-mutated non-small cell lung cancer with disease progression following standard treatment with EGFR TKIs and platinum-based chemotherapy are limited,” said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. “HER3 represents a novel target for therapeutic development as it is broadly expressed in non-small cell lung cancer. These results are encouraging since the safety profile was consistent with previous findings and response to patritumab deruxtecan was seen irrespective of the level of HER3 expression or mechanism of resistance to prior therapies.”

Patients receiving 5.6 mg/kg (n=57) of patritumab deruxtecan were pre-treated with a median of four prior lines of therapy (range, 1-9), including EGFR TKIs (100%), platinum-based chemotherapy (91%) and immunotherapy (40%). A majority (86%) were previously treated with osimertinib. Of the 57 patients, 27 patients had brain metastases at baseline. As of data cut-off on September 24, 2020, 32% of patients remain on treatment with patritumab deruxtecan.

Summary of Results

Efficacy Measure

HER3-DXd Dose Escalation 5.6 mg/kg

Plus Dose Expansion 5.6 mg/kg (n=57) iv

Prior TKI±PBC

(n=57)

Prior OSI and PBC

(n=44)

ORR (%) (95% CI) i, ii

39% (26-52)

39% (24-55)

CR (%)

2%

2%

PR (%)

37%

36%

SD (%)

33%

30%

PD (%)

16%

18%

NE (%)

12%

14%

DCR (%) (95% CI)iii

72% (59-83)

68% (52-81)

Time to response (months)

2.6 months (1.2-5.4)

2.7 months (1.2-5.4)

Median DOR (months) (95% CI)

6.9 months (3.1-NE)

7.0 months (3.1-NE)

Median PFS (months) (95% CI)

8.2 months (4.4-8.3)

8.2 months (4.0-NE)

CI, confidence interval; CR, complete response; DCR, disease control rate; DOR, duration of response; OSI, osimertinib; NE, not estimable; PBC, platinum-based chemotherapy; PD, progressive disease; PR, partial response; PFS, progression-free survival; SD, stable disease; TKI; tyrosine kinase inhibitor

i As assessed by independent central review

ii ORR is (CR + PR)

iii DCR is (CR + PR + SD)

iv Median follow up: 10.2 (range, 5.2-19.9) months

About the Phase 1 Non-Small Cell Lung Cancer Study

The global, multicenter, open label, two-part phase 1 study is evaluating patritumab deruxtecan in previously treated patients with metastatic or unresectable NSCLC.

The dose escalation part of the study evaluated patients with EGFR-mutated disease either with progression on osimertinib or T790M-negative after progression on erlotinib, gefitinib or afatinib. The primary objective of this part of the study was to assess the safety and tolerability of patritumab deruxtecan and determine the recommended dose for expansion (RDE).

The dose expansion part of the study is evaluating patritumab deruxtecan at the RDE (5.6 mg/kg every three weeks) in three cohorts. Cohort 1 includes patients with locally advanced or metastatic EGFR-mutated NSCLC who experienced disease progression after taking one or more EGFR TKIs and one or more platinum based chemotherapy regimens. Cohort 2 includes patients with squamous or non-squamous NSCLC without EGFR-activating mutations following platinum-based chemotherapy and following an anti-PD-1 or anti-PD-L1 antibody regimen. Cohort 3 includes patients with NSCLC with EGFR-activating mutations including any histology other than combined small cell and non-small cell lung cancer; patients in Cohort 3 are randomized 1:1 to receive the 5.6 mg/kg RDE regimen (Cohort 3a) or an escalating up-titration regimen of patritumab deruxtecan (Cohort 3b).

Preliminary data from the dose escalation part of the study were presented previously at the 2019 World Conference on Lung Cancer, and early data from the dose escalation part (5.6 mg/kg dose) and Cohort 1 of the dose expansion were presented at the 2020 European Society of Medical Oncology (ESMO) Virtual Congress. Exploratory biomarker analyses assessing genomic alterations of patient tumors were presented at the 2020 World Conference on Lung Cancer.

The primary objective of the dose expansion part of the study is to assess efficacy of patritumab deruxtecan as measured by confirmed objective response rate assessed by blinded independent central review. Secondary study endpoints include investigator-assessed objective response rate; safety, tolerability and preliminary efficacy; and characterization of the pharmacokinetics of patritumab deruxtecan. The study enrolled patients at multiple sites in the U.S., Europe, Japan and other countries in Asia. For more information, visit ClinicalTrials.gov.

About Non-Small Cell Lung Cancer

Lung cancer is the most common cancer and the leading cause of cancer mortality worldwide. There were an estimated 2.2 million new cases of lung cancer and 1.8 million deaths in 2020.3 Most lung cancers are diagnosed at an advanced or metastatic stage.4 Non-small cell lung cancer (NSCLC) accounts for 80 to 85% of all lung cancers.5

The introduction of targeted therapies and checkpoint inhibitors in the past decade has improved the treatment landscape for patients with advanced or metastatic NSCLC; however, the prognosis is particularly poor among patients who have progressed after treatment with standard therapies. For patients who are not eligible for current treatments, or whose cancer continues to progress, new therapeutic approaches are needed.6

The mutationally-activated EGFR tyrosine kinase is a well-established oncogenic driver and molecular target for management of advanced stage NSCLC.7 For patients with advanced EGFR-mutated NSCLC, targeted therapy with EGFR TKIs offer higher response rates and progression-free survival compared to chemotherapy.7 However, most patients eventually develop resistance to these therapies, and standard treatment options are limited.8 Treatment options used in this setting historically have demonstrated limited efficacy with progression free survival of up to 6.4 months for platinum-based chemotherapy and 3.2 months for other salvage therapies.3,9 New treatment approaches are needed to overcome resistance and improve survival in these patients.

About HER3

HER3 is a member of the EGFR family of receptor tyrosine kinases, which are associated with aberrant cell proliferation and survival.10 Approximately 25 to 30% of lung cancers worldwide have an EGFR-activating mutation, and it is estimated that about 83% of all NSCLC tumors express the HER3 protein, which can be associated with an increased incidence of metastases, reduced survival and resistance to standard of care treatment.11,12,13 Currently, no HER3 directed medicines are approved for the treatment of cancer.

About Patritumab Deruxtecan

Patritumab deruxtecan (HER3-DXd) is one of three lead DXd ADCs in the oncology pipeline of Daiichi Sankyo. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, patritumab deruxtecan is comprised of a human anti-HER3 antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker.

Patritumab deruxtecan is currently being evaluated in a comprehensive development program across multiple cancers as both a monotherapy and in combination with other anticancer treatments. The development program includes HERTHENA-Lung01, a pivotal phase 2 study in patients with locally advanced or metastatic EGFR-mutated NSCLC previously treated with a TKI and platinum-based chemotherapy; a phase 2 study in patients with advanced/metastatic colorectal cancer with disease progression following at least two prior lines of systemic therapy; a phase 1/2 study in HER3 expressing metastatic breast cancer; a phase 1 study in combination with osimertinib in locally advanced/metastatic EGFR-mutated NSCLC; and, a phase 1 study in previously treated patients with metastatic or unresectable NSCLC.

Patritumab deruxtecan is an investigational medicine that has not been approved for any indication in any country. Safety and efficacy have not been established.

About Daiichi Sankyo

Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose “to contribute to the enrichment of quality of life around the world.” In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an “Innovative Global Healthcare Company Contributing to the Sustainable Development of Society.” For more information, please visit www.daiichisankyo.com.

References:

1 Engelman JA, et al. Science. 2007;316:1039-1043.

2 Schoenfield AJ, et al. J Thorac Oncol 2020;15:18-21.

3 Yang CJ, et al. BMC Pharmcol Toxicol. 2017,18(1).

4 World Health Organization. GLOBOCAN 2020. Lung Cancer Fact Sheet. January 2021.

5 American Cancer Society. Lung Cancer Early Detection, Diagnosis. May 2021.

6 American Cancer Society. Types of Non-Small Cell Lung Cancer. 2019.

7 Economopoulou P, et al. Ann Transl Med. 2018;6(8):138.

8 Planchard D, et al. Ann Oncol. 2018;29(4):iv192–237.

9 Morgillo F, et al. ESMO Open. 2016;1:e000060.

10 Han B, et al. Onco Targets Ther 2018;11; 2121-2129.

11 Mishra R, et al. Oncol Rev. 2018;12:355.

12 Zhang YL, et al. Oncotarget. Vol. 7 No 49. 78985-78993.

13 Muller-Tidow C, et al. Cancer Res. 2005;65:1778-1772.

14 Scharpenseel, et al. Scientific Reports. 2019;9:7406.

Contacts

Global/US:
Sarah McGovern

Daiichi Sankyo, Inc.

smcgovern@dsi.com
+1 908 992 6614 (office)

+1 908 821 7376 (mobile)

EU:
Lydia Worms

Daiichi Sankyo Europe GmbH

lydia.worms@daiichi-sankyo.eu
+49 (89) 7808751 (office)

+49 176 11780861 (mobile)

Japan:
Masashi Kawase

Daiichi Sankyo Co., Ltd.

kawase.masashi.a2@daiichisankyo.co.jp
+81 3 6225 1126 (office)

Investor Relations Contact:
DaiichiSankyoIR@daiichisankyo.co.jp

Categories
Business

AM Best assigns credit ratings to Westfield Specialty Insurance Company

OLDWICK, N.J. — (BUSINESS WIRE) — AM Best has assigned a Financial Strength Rating (FSR) of A (Excellent) and a Long-Term Issuer Credit Rating (Long-Term ICR) of “a+” (Excellent) to Westfield Specialty Insurance Company (Westfield Specialty). The outlook assigned to these Credit Ratings (ratings) is stable. This company is a newly added member of Westfield Group (Westfield). All members are wholly owned subsidiaries of Ohio Farmers Insurance Company (Ohio Farmers), the ultimate parent.

The ratings reflect Westfield Specialty’s balance sheet strength, which AM Best assesses as strongest, as well as its adequate operating performance, neutral business profile and appropriate enterprise risk management. The ratings of the members of Ohio Farmers are being extended to Westfield Specialty given the explicit support provided through a pooling arrangement. The operations of the new subsidiary are fully integrated with the other pooled members of the group. Westfield Specialty will provide flexible nonstandard product underwriting opportunities to new and existing commercial customers.

This press release relates to Credit Ratings that have been published on AM Best’s website. For all rating information relating to the release and pertinent disclosures, including details of the office responsible for issuing each of the individual ratings referenced in this release, please see AM Best’s Recent Rating Activity web page. For additional information regarding the use and limitations of Credit Rating opinions, please view Guide to Best’s Credit Ratings. For information on the proper media use of Best’s Credit Ratings and AM Best press releases, please view Guide for Media – Proper Use of Best’s Credit Ratings and AM Best Rating Action Press Releases.

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

Copyright © 2021 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Jeffrey Stary, CPCU, Are, ARM
Financial Analyst
+1 908 439 2200, ext. 5689
jeffrey.stary@ambest.com

Jacqalene Lentz, CPA
Director
+1 908 439 2200, ext. 5762
jacqalene.lentz@ambest.com

Christopher Sharkey
Manager, Public Relations
+1 908 439 2200, ext. 5159
christopher.sharkey@ambest.com

Jim Peavy
Director, Communications
+1 908 439 2200, ext. 5644
james.peavy@ambest.com

Categories
Business

1792 Wealth Advisors snags two veteran advisors as practice pushes retirement focus

New additions show demand for supported independence model

 

MORRISTOWN, N.J. — (BUSINESS WIRE) — 1792 Wealth Advisors (1792), is expanding its footprint in northern New Jersey with the addition of two veteran-advisor led practices. The Raymond James-backed advisory platform is bringing on Elise Feldman, AIF, who has 30 years of experience and has been working as a solo practitioner within the Raymond James complex alongside Christopher Marlar, who comes over from Ladenburg Thalman.


“We have been diligently building our model for supported independence and it serves as a huge endorsement for what we are doing when seasoned advisors of Elise’s and Christopher’s caliber recognize what value we can bring,” asserts Bob Milligan, managing partner and founder of 1792 Advisors.

 

While Feldman and Marlar have a shared appreciation for the autonomy given to advisors at 1792, the two focus in different areas of the business. Feldman’s addition will serve as a beachhead for the organization’s assertive move into the retirement plan arena, a piece of the business that Milligan feels is ripe with opportunity. Marlar has zeroed in on the delivery of high-touch financial planning for affluent individuals and families. Marlar was looking for a platform partner that provided the same high touch service for advisors as he delivers for clients.

 

“As a solo practitioner, I wanted to prepare my clients for the long-term and it’s in their best interest for me to partner with 1792 for both the added support, services but also maintaining consistency for those clients’ lifelong planning needs,” says Feldman. “Finding a new level of supported independence within the Raymond James community was important in being able to limit disruption for my clients. Additionally, 1792 placed a real value on my specialization in qualified retirement plans, non-qualified plans and welfare benefit plans. With the practice’s backing, I feel that area has a significant opportunity for growth.”

 

Feldman’s move to 1792 mirrors Marlar in that both were seeking to leverage their time better with their clients. With over 20 years of experience working in asset management and retirement planning, Marlar transitioned to supported independence via 1792 to better serve individuals and businesses that he works with, offer a top of the line experience and obtain additional operational support. “My goal is to do what’s best for my clients, and it was clear that 1792 has client service and advocacy as a culture as a top priority,” Marlar explains. “1792 and Raymond James make it easy to offer concierge service and high-touch financial planning with back-end support so I can spend more time working with clients.”

 

After four years of building the office, 1792 is continuing its growth trajectory and is gearing up for future expansion in the region. “I’m excited to build on this momentum. So many advisors are looking to make the move to independence, and we’re here to support those transitions. I’ve done it, and I can help other advisors avoid missteps and make the move that much easier,” says Milligan.

 

The organization plans to open a second office in Morristown by year-end as well as move into Red Bank, Short Hills and Bergen County over the next 24 months.

 

About 1792 Wealth Advisors

1792 Wealth Advisors is a premier platform for advisors seeking supported independence. With the support of Raymond James we are able to offer industry-leading resources, technology and support while providing control of and equity in their own business. We know advisors do best when supporting each other, and our approach of supported independence offers advisors better economics and enhanced culture.

For more information, visit Join1792.com or https://www.raymondjames.com/1792wealthadvisors.

Contacts

Haley Rosa

Gregory FCA

haley@gregoryfca.com
610-228-2805

Categories
Business Technology

Seaborn Networks appoints Eric Brooks as senior vice president, sales and marketing, North America

BOSTON — (BUSINESS WIRE) — #Connectivity—Seaborn Networks (“Seaborn”), a leading developer-owner-operator of submarine fiber optic cable systems, announced today the appointment of Eric Brooks as Senior Vice President of Sales and Marketing, North America. Eric will lead Seaborn’s North America sales organization, channel and marketing strategies.


Eric comes to Seaborn from network solutions provider Zayo Group where he was Senior Vice President of Sales for seven years. In that role Eric managed global teams in multiple areas including sales, marketing, channel and engineering. Prior to Zayo, Eric was Sales Director at Level 3 Communications focused on the large enterprise market including media, content and gaming segments.

 

“I have known Eric over the last 10 years and am excited to add him in a critical role to our executive team,” said Steve Orlando, Seaborn’s CEO. “Eric’s strategic leadership, business acumen and market reputation will be an invaluable addition to Seaborn as we continue to grow our world class subsea networks and global IP peering relationships.”

 

About Seaborn

Seaborn is a leading developer-owner-operator of submarine fiber optic cable systems addressing global communications needs across the Americas, including Seabras-1 and AMX-1 between Brazil and the USA. Seabras-1 is the only direct POP to POP system between São Paulo and New York metro, offering the most direct, low latency route between the B3 exchange in São Paulo and the trading exchanges of New Jersey. Seaborn’s industry leading service delivery and performance combined with our IP and Ethernet service offerings broadens our solutions driven approach and commitment to always exceeding the service expectations of our customers. For more information, please visit www.seabornnetworks.com and follow us on LinkedIn.

Contacts

Media Contact:
Naaz Bax, Head of Marketing

media-relations@seabornnetworks.com

Categories
Business Technology

Janus International to participate in the KeyBanc Industrials Conference

TEMPLE, Ga. — (BUSINESS WIRE) — Janus International Group, LLC (“Janus” or the “Company”), a leading global manufacturer and supplier of turn-key building solutions and new access control technologies for the self-storage and other industrial sectors, announced today that members of Janus management will participate in the KeyBanc Industrials Conference on Friday, June 4, 2021.

Janus expects to complete its business combination with Juniper Industrial Holdings, Inc. (NYSE: JIH) and become a publicly listed company soon after the special meeting of shareholders scheduled for June 3, 2021. Clearlake, an investment firm, is the largest shareholder in Janus.

ABOUT JANUS INTERNATIONAL

Janus International Group, LLC (www.JanusIntl.com) is the leading global manufacturer and supplier of turn-key self-storage, commercial and industrial building solutions, including: roll-up and swing doors, hallway systems, re-locatable storage units and facility and door automation technologies. The Janus team operates out of several U.S. locations and six locations internationally.

ABOUT CLEARLAKE

Founded in 2006, Clearlake Capital Group, L.P. is an investment firm operating integrated businesses across private equity, credit and other related strategies. With a sector-focused approach, the firm seeks to partner with experienced management teams by providing patient, long term capital to dynamic businesses that can benefit from Clearlake’s operational improvement approach, O.P.S.® The firm’s core target sectors are industrials, technology, and consumer. Clearlake currently has approximately $35 billion of assets under management, and its senior investment principals have led or co-led over 300 investments. The firm has offices in Santa Monica and Dallas. More information is available at www.clearlake.com and on Twitter @ClearlakeCap.

ABOUT JUNIPER INDUSTRIAL HOLDINGS, INC. (NYSE: JIH)

Juniper Industrial Holdings, Inc., a Delaware corporation (“JIH” or “Juniper”), is a Special Purpose Acquisition Corporation targeting companies within the industrials sector. With $348 million in trust, Juniper was formed for the purpose of entering into a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or similar business combination with one or more businesses. Juniper’s management team has a proven track record of identifying market-leading technologies across the industrial spectrum, and an affinity for businesses with strong brands and mission-critical offering. The Juniper team has a robust network of relationships within industrial and investment communities built over 60+ years of combined industry experience, and a deep understanding of industrial trends. More information is available at www.juniperindustrial.com.

IMPORTANT INFORMATION AND WHERE TO FIND IT

This communication is being made in connection with the proposed business combination involving Juniper and Janus under a new holding company, Janus Parent, Inc., a Delaware corporation (“Janus Parent”). In connection with the proposed transactions, Janus Parent has filed with the Securities and Exchange Commission (“SEC”) a registration statement on Form S-4 (as amended, the “Registration Statement”) containing a definitive proxy statement of Juniper and a definitive prospectus of Janus Parent. This announcement does not contain all the information that should be considered concerning the proposed business combination and is not intended to form the basis of any investment decision or any other decision in respect of the business combination. Juniper’s shareholders and other interested persons are advised to read the definitive proxy statement/prospectus and other documents filed in connection with the proposed business combination, as these materials will contain important information about Juniper, Janus, Janus Parent and the business combination. Janus Parent has mailed the definitive proxy statement/prospectus and other relevant materials for the proposed business combination to shareholders of Juniper as of May 4, 2021 for voting on the proposed business combination. Shareholders are also able to obtain copies of the definitive proxy statement/prospectus and other documents filed with the SEC, without charge at the SEC’s website at www.sec.gov. In addition, the documents filed by Juniper and Janus Parent may be obtained free of charge from Juniper at www.juniperindustrial.com/investors. Alternatively, these documents can be obtained free of charge by directing a request to: Juniper Industrial Holdings, Inc., 14 Fairmount Avenue, Chatham, New Jersey 07928.

PARTICIPANTS IN THE SOLICITATION

Juniper, Janus and certain of their directors and executive officers may be deemed participants in the solicitation of proxies from Juniper’s shareholders with respect to the proposed business combination. A list of the names of those directors and executive officers and a description of their interests in Juniper is contained in Juniper’s annual report on Form 10-K for the fiscal year-ended December 31, 2020, which is available free of charge at the SEC’s web site at www.sec.gov. In addition, the documents filed by Juniper may be obtained from Juniper as described above under “Important Information and Where to Find It.”

NO OFFER OR SOLICITATION

This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval, nor shall there be any sale of any securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of such other jurisdiction.

FORWARD LOOKING STATEMENTS

Certain statements in this communication may be considered “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact included in this communication are forward-looking statements. When used in this communication, words such as “may,” “should,” “could,” “would,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “continue,” or the negative of such terms or other similar expressions, as they relate to the management team, identify forward-looking statements. Such forward-looking statements are based on the current beliefs of the respective management of Janus and Juniper, based on currently available information, as to the outcome and timing of future events, and involve factors, risks, and uncertainties that may cause actual results in future periods to differ materially from such statements. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors detailed in Juniper’s filings with the SEC including, but not limited to, the risk factors and other uncertainties set forth under “Risk Factors” in Part I, Item 1A of Juniper’s Form 10-K for the year ended December 31, 2020 and in Juniper’s other filings. There can be no assurance that the events, results or trends identified in these forward-looking statements will occur or be achieved. Forward-looking statements speak only as of the date they are made, and neither Janus nor Juniper is under any obligation, and each of them expressly disclaims any obligation, to update, alter or otherwise revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. All subsequent written or oral forward-looking statements attributable to Janus or Juniper or persons acting on its behalf are qualified in their entirety by this paragraph.

In addition to factors previously disclosed in Juniper’s reports filed with the SEC and those identified elsewhere in this communication, the following factors, among others, could cause actual results to differ materially from forward-looking statements or historical performance: (i) ability to meet the closing conditions to the merger, including approval by stockholders of Juniper on the expected terms and schedule and the risk that any regulatory approvals required for the merger are not obtained or are obtained subject to conditions that are not anticipated; (ii) the occurrence of any event, change or other circumstance that could cause the termination of the merger agreement or a delay in the closing of the merger; (iii) the effect of the announcement or pendency of the proposed merger on Juniper’s business relationships, operating results, and business generally; (iv) failure to realize the benefits expected from the proposed transaction; (v) risks that the proposed merger disrupts Janus’s current plans and operations and potential difficulties in Janus’s employee retention as a result of the proposed merger; (vi) the effects of pending and future legislation; (vii) risks related to disruption of management time from ongoing business operations due to the proposed transaction; (viii) the amount of the costs, fees, expenses and other charges related to the merger; (ix) risks of the self-storage industry; (x) the highly competitive nature of the self-storage industry and Janus’s ability to compete therein; (xi) litigation, complaints, and/or adverse publicity; (xii) the ability to meet NYSE’s listing standards following the consummation of the proposed transaction and (xiii) cyber incidents or directed attacks that could result in information theft, data corruption, operational disruption and/or financial loss.

This communication is not intended to be all-inclusive or to contain all the information that a person may desire in considering an investment in Juniper and is not intended to form the basis of an investment decision in Juniper. All subsequent written and oral forward-looking statements concerning Janus and Juniper, the proposed transaction or other matters and attributable to Janus and Juniper or any person acting on their behalf are expressly qualified in their entirety by the cautionary statements above. Juniper and Janus undertake no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

Contacts

Investor Contacts, Janus
Rodny Nacier/ Brad Cray

Phone: 770-562-6399

Email: IR@JanusIntl.com

Media Contacts, Janus
Phil Denning / Nora Flaherty

Media@janusintl.com

Media Contacts, Clearlake
Jennifer Hurson

JHurson@lambert.com

Categories
Business Local News

Bristol Myers Squibb data at EULAR 2021 highlight commitment to driving advancements across multiple immune-mediated rheumatic diseases

PRINCETON, N.J. — (BUSINESS WIRE) — $BMY #Deucravacitinib—Bristol Myers Squibb (NYSE:BMY) today announced that data from 28 company-sponsored and investigator-sponsored studies will be presented at the EULAR 2021 Virtual Congress taking place June 2-5, 2021. The research highlights the depth and strength of the company’s growing immunology pipeline and portfolio, commitment to the rheumatology research community and focus on delivering meaningful solutions that address unmet patient needs across immune-mediated diseases.

Research will be shared on multiple Bristol Myers Squibb assets spanning several disease areas, including:

  • Deucravacitinib: An analysis of musculoskeletal disease improvements from the Phase 2 trial evaluating deucravacitinib, a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor, in active psoriatic arthritis reveals that patients treated with deucravacitinib showed consistent improvement across all American College of Rheumatology (ACR) components versus placebo-treated patients, ACR 20 responses were consistent regardless of prior TNF experience, and soft tissue manifestations such as enthesitis were completely resolved in half of patients.
    • These data (abstract OP0227) will be featured as an oral presentation on Friday, June 4 from 10:15 a.m. – 11:45 a.m. CEST. Additionally, a poster (POS0198) on the Phase 2 results previously announced at ACR Convergence in November 2020 will be presented on Friday, June 4 from 11:50 a.m. – 1:30 p.m. CEST.
    • Author: Mease
  • Orencia (abatacept): A real-world analysis showing that patients with rheumatoid factor (RF) positive and anti-citrullinated protein antibodies (ACPA) positive rheumatoid arthritis, known as “double positive,” treated with Orencia as a first-line treatment had higher retention than patients receiving Orencia as a second-line or later therapy. Patients with RF and ACPA are considered to have more highly active, progressive RA and a poor disease prognosis. Remission rates on Orencia were higher in patients with double positive RA versus double negative RA.
    • These data (abstract OP0180) will be featured as an oral presentation on Thursday, June 3 from 10:15 a.m. – 11:45 a.m. CEST.
    • Author: Alten
  • Iberdomide: Findings from the Phase 2b trial in patients with active systemic lupus erythematosus (SLE) assessing effects of iberdomide on cutaneous (skin) manifestations in SLE. Iberdomide is a novel, oral, high-affinity, cereblon ligand that induces degradation of transcription factors Aiolos and Ikaros, which play critical roles in immune cell development and regulating the balance of the immune system and are linked to the genetic risk for SLE. The study showed beneficial effects on skin manifestations in patients with SLE treated with iberdomide. Efficacy appeared to be more pronounced in patients with subacute cutaneous lupus erythematosus (SCLE) and chronic cutaneous lupus erythematosus (CCLE) subtypes.
    • These data (abstract OP0132) will be featured as an oral presentation on Thursday, June 3 from 10:15 a.m. – 11:45 a.m. CEST.
    • Author: Werth

“Rheumatic diseases can be debilitating for the tens of millions of people worldwide who live with these conditions. With the understanding that these diseases can behave very differently from person to person, Bristol Myers Squibb is pursuing pathbreaking science to tailor therapies to individual needs, improve outcomes and expand treatment options,” said Mary Beth Harler, M.D., head of Immunology and Fibrosis Development, Bristol Myers Squibb. “Our presentations at EULAR, which span early discovery, late-stage studies and real-world data, represent our robust and growing Immunology pipeline and portfolio, and our focus on driving forward the next wave of immune-modulators and precision medicines.”

Bristol Myers Squibb-sponsored abstracts that will be presented at EULAR 2021 can be found below. Complete abstracts may be accessed online here.

Deucravacitinib Presentations

  • Efficacy of Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 Inhibitor, in Musculoskeletal Manifestations of Active Psoriatic Arthritis in a Phase 2, Randomized, Double-Blind, Placebo-Controlled TrialAuthor: Mease

    Abstract Number: OP0227

    Session Title: Psoriatic Arthritis – Treatment

    Friday, June 4, 10:15 a.m. – 11:45 a.m. CEST

    Oral Presentation

  • Efficacy and Safety of Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 Inhibitor, in Patients with Active Psoriatic Arthritis: Results from a Phase 2, Randomized, Double-Blind, Placebo-Controlled TrialAuthor: Mease

    Abstract Number: POS0198

    Session Title: PsA Treatment: What is New?

    Poster Tour: Friday, June 4, 11:50 a.m. – 1:30 p.m. CEST

  • Efficacy and Safety of Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 (TYK2) Inhibitor, Compared with Placebo and Apremilast in Moderate to Severe Plaque Psoriasis: Results from the Phase 3 POETYK PSO-1 StudyAuthor: Armstrong

    Abstract Number: POS1042

    Poster View: Wednesday, June 2, 8:00 a.m. – Monday, July 5, 11:59 p.m. CEST

Orencia Presentations

  • Impact of RF and ACPA Serostatus on 2-Year Retention of Abatacept in Patients with RAAuthor: Alten

    Abstract Number: OP0180

    Session Title: Rheumatoid Arthritis – Prognosis, Predictors and Outcomes

    Thursday, June 3, 10:15 a.m. – 11:45 a.m. CEST

    Oral Presentation

  • Implementation of the OMERACT PsAMRIS in a Phase IIb, Randomised Placebo-Controlled Study of Abatacept in Psoriatic ArthritisAuthor: Østergaard

    Abstract Number: POS1040

    Poster View: Wednesday, June 2, 8:00 a.m. – Monday, July 5, 11:59 p.m. CEST

  • Disease Activity in Patients with RA by Serostatus and Treatment Line, Following Treatment with Abatacept: Results From an International Observational StudyAuthor: Alten

    Abstract Number: POS0599

    Poster View: Wednesday, June 2, 8:00 a.m. – Monday, July 5, 11:59 p.m. CEST

  • Physical Function in Patients with RA, Stratified by Serostatus And Treatment Line, Following SC Abatacept: Post Hoc Analysis of an Observational, 2-Year Study Conducted in Routine Clinical Practice (ASCORE)Author: Alten

    Abstract Number: POS0447

    Poster View: Wednesday, June 2, 8:00 a.m. – Monday, July 5, 11:59 p.m. CEST

  • S100A8/A9 and S100A12 as Potential Predictive Biomarkers of Abatacept Response in Polyarticular Juvenile Idiopathic ArthritisAuthor: Ruperto

    Abstract Number: POS0076

    Session Title: Pediatric Rheumatology – Clinical

    Poster Tour: Thursday, June 3, 11:50 a.m. – 1:30 p.m. CEST

  • Analysis of Factors Associated with the Effectiveness of Abatacept in the ORIGAMI StudyAuthor: Misaki

    Abstract Number: POS0603

    Poster View: Wednesday, June 2, 8:00 a.m. – Monday, July 5, 11:59 p.m. CEST

Iberdomide Presentation

  • Effect of Iberdomide on Cutaneous Manifestations in Systemic Lupus Erythematosus: Results of a 24-Week, Placebo-Controlled, Phase 2 StudyAuthor: Werth

    Abstract Number: OP0132

    Session Title: SLE, Sjögren’s and APS – Treatment and SLE, Sjögren’s and APS – Clinical Aspects (Other Than Treatment)

    Thursday, June 3, 10:15 a.m. – 11:45 a.m. CEST

    Oral Presentation

Early Asset Presentation

  • Investigating the Anti-Inflammatory Potential of a Novel MK2 Inhibitor in a Vitro Model of EnthesitisAuthor: Bridgewood

    Abstract Number: POS0408

    Poster View: Wednesday, June 2, 8:00 a.m. – Monday, July 5, 11:59 p.m. CEST

Health Economics and Outcomes Research (HEOR) Presentations

  • Epidemiology and Mortality of RA-Associated Interstitial Lung Disease: Data from a French Administrative Healthcare DatabaseAuthor: Juge

    Abstract Number: OP0099

    Session Title: Rheumatoid Arthritis – Comorbidity and Clinical Aspects – I

    Thursday, June 3, 10:15 a.m. – 11:45 a.m. CEST

    Oral Presentation

  • Estimated Prevalence, Incidence and Healthcare Costs of Sjögren’s Syndrome in France: A National Claims-Based StudyAuthor: Seror

    Abstract Number: POS0024

    Session Title: Epidemiology: Big Questions – Big Studies

    Poster Tour: Thursday, June 3, 11:50 a.m. – 1:30 p.m. CEST

  • Extrapolation of Long-Term Outcomes in Systemic Lupus Erythematosus: Replicating a Hopkins Lupus Cohort Analysis with the Systemic Lupus International Collaborating Clinics (SLICC) Inception CohortAuthor: Clarke

    Abstract Number: POS0734

    Poster View: Wednesday, June 2, 8:00 a.m. – Monday, July 5, 11:59 p.m. CEST

  • Substantial Impact of Autoantibody Enrichment on Outcomes in Early Rheumatoid Arthritis Treated with Abatacept: Data from a Large Pooled Analysis of 4 RCTsAuthor: Michaud

    Abstract Number: POS0474

    Poster View: Wednesday, June 2, 8:00 a.m. – Monday, July 5, 11:59 p.m. CEST

  • Risk of ACPA Positivity by Motif-Based Classification of HLA-DRB1 Shared Epitope Alleles in RAAuthor: Wipfler

    Abstract Number: POS0344

    Poster View: Wednesday, June 2, 8:00 a.m. – Monday, July 5, 11:59 p.m. CEST

Abstract Book Publications

  • Effect of Deucravacitinib on the Psoriatic Arthritis Impact of Disease (PsAID) Questionnaires 12 and 9: Analysis of a Phase 2 Study of Active Psoriatic ArthritisAuthor: Gossec

    Abstract Number: AB0560

  • A Novel Method for Predicting 1-Year Retention of Abatacept Using Machine Learning Techniques: Directionality and Importance of PredictorsAuthor: Alten

    Abstract Number: AB0205

  • Analysis of Abatacept Treatment Retention and Efficacy According to Disease Duration and Treatment Line in a Real-World SettingAuthor: Alten

    Abstract Number: AB0207

  • Changes in Extracellular Matrix Biomarker C3M Correlate with Abatacept Response in Seropositive Early RAAuthor: Bridges

    Abstract Number: AB0107

  • Improvement in Clinical Disease Activity and Patient-Reported Outcomes After 6 Months of Treatment with Abatacept, Stratified by Line of Therapy, in Patients with RA: Results from a Large, US, National Observational StudyAuthor: Harrold

    Abstract Number: AB0202

  • Construction of the Veterans Affairs National Rheumatoid Arthritis Database (VANRAD)Author: Joseph

    Abstract Number: AB0128

About Psoriatic Arthritis

Psoriatic arthritis is a chronic, immune-mediated, heterogenous disease with multiple musculoskeletal and skin manifestations, including inflammatory arthritis, enthesitis (which occurs when the connective tissue between tendons or ligaments and bone called enthesis becomes inflamed), dactylitis (inflammation and swelling of the fingers and toes), spinal inflammation and psoriatic skin and nail lesions. Up to 42 percent of patients with psoriasis may develop psoriatic arthritis. In addition to the loss of physical function, pain and fatigue caused by psoriatic arthritis, the disease can significantly impact the mental and emotional well-being of patients. Additionally, patients with psoriatic arthritis are at increased risk of developing serious comorbidities, including cardiovascular disease, metabolic syndrome and depression, as well as extraarticular manifestations of disease, such as inflammatory bowel disease.

About Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a destructive immune-mediated disease of the joints characterized by inflammation in the joint lining (or synovium), leading to joint damage with chronic pain, stiffness and swelling. RA causes limitations in range of motion and decreased joint function with long-term disability. Women are three times more likely than men to develop RA.

About Lupus

Lupus is a chronic, complex immune-mediated disease that results in the immune system attacking multiple organs in the body. Lupus most often affects the joints, skin, kidneys, blood vessels, blood cells, brain, and lungs, causing widespread inflammation and tissue damage in the affected organ(s). There are more than five million people around the world with a form of lupus, and it is most often diagnosed in young women between the ages of 15 and 44. The most common type of lupus is systemic lupus erythematosus (SLE), which accounts for approximately 70 percent of all lupus cases. Within five years of disease onset, 40-60 percent of patients with SLE develop lupus nephritis (renal involvement), the most important predictor of SLE morbidity and mortality.

About Deucravacitinib

Deucravacitinib (pronounced doo-krav-a-sih-ti-nib) is a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action. Deucravacitinib is the first and only TYK2 inhibitor in clinical studies across multiple immune-mediated diseases. Bristol Myers Squibb scientists designed deucravacitinib to selectively target TYK2, thereby inhibiting signaling of interleukin (IL)-12, IL-23 and Type 1 interferon (IFN), key cytokines involved in the pathogenesis of multiple immune-mediated diseases. Deucravacitinib achieves a high degree of selectivity by binding to the regulatory domain of TYK2, resulting in allosteric inhibition of TYK2 and its downstream functions. Deucravacitinib selectively inhibits TYK2, unlike approved Janus kinase (JAK) 1, 2 and 3 inhibitors, at physiologically relevant concentrations. At therapeutic doses, deucravacitinib does not inhibit JAK1, JAK2 or JAK3. Due to the innovative design of deucravacitinib, Bristol Myers Squibb earned recognition with the 2019 Thomas Alva Edison Patent Award for the science underpinning the clinical development of deucravacitinib.

Deucravacitinib is being studied in multiple immune-mediated diseases, including psoriasis, psoriatic arthritis, lupus and inflammatory bowel disease. Deucravacitinib is not approved for use in any country.

About Iberdomide

Iberdomide is a novel, oral, high-affinity, cereblon ligand that induces degradation of transcription factors Aiolos and Ikaros, which play critical roles in immune cell development and regulating the balance of the immune system and are genetically linked to the risk of developing lupus and other diseases. Iberdomide is currently under investigation for the treatment of multiple myeloma, lymphoma and lupus and is not approved for use in any country.

About Orencia

Orencia is an immunomodulator that disrupts the continuous cycle of T-cell activation that characterizes RA, psoriatic arthritis and juvenile idiopathic arthritis (JIA). In RA, Orencia targets unique and fundamental drivers of the disease, resulting in improved efficacy and durability in seropositive RA patients (patients with key biomarkers of the disease). Approved for RA by the FDA in 2005 and by the European Commission in 2007, Orencia is an established treatment with a proven safety profile across the disease continuum.

U.S. Indications/Usage and Important Safety Information for ORENCIA® (abatacept)

Indications and Usage

Adult Rheumatoid Arthritis: ORENCIA® (abatacept) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

Polyarticular Juvenile Idiopathic Arthritis: ORENCIA is indicated for the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA).

Adult Psoriatic Arthritis: ORENCIA is indicated for the treatment of adult patients with active psoriatic arthritis (PsA).

Limitations of Use: The concomitant use of ORENCIA with other potent immunosuppressants [e.g., biologic disease-modifying antirheumatic drugs (bDMARDS), Janus kinase (JAK) inhibitors] is not recommended.

Important Safety Information for ORENCIA® (abatacept)

Concomitant Use with TNF Antagonists, Other Biologic RA/PsA Therapy, or JAK Inhibitors: Concurrent therapy with ORENCIA and a TNF antagonist is not recommended. In controlled clinical trials, adult RA patients receiving concomitant intravenous ORENCIA and TNF antagonist therapy experienced more infections (63% vs 43%) and serious infections (4.4% vs 0.8%) compared to patients treated with only TNF antagonists, without an important enhancement of efficacy. Additionally, concomitant use of ORENCIA with other biologic RA/PsA therapy or JAK inhibitors is not recommended.

Hypersensitivity: There were 2 cases (<0.1%; n=2688) of anaphylaxis reactions in clinical trials with adult RA patients treated with intravenous ORENCIA. Other reactions potentially associated with drug hypersensitivity, such as hypotension, urticaria, and dyspnea, each occurred in <0.9% of patients. There was one case of a hypersensitivity reaction with ORENCIA in pJIA clinical trials (0.5%; n=190). In postmarketing experience, fatal anaphylaxis following the first infusion of ORENCIA and life-threatening cases of angioedema have been reported. Angioedema has occurred as early as after the first dose of ORENCIA, but also has occurred with subsequent doses. Angioedema reactions have occurred within hours of administration and in some instances had a delayed onset (i.e., days). Appropriate medical support measures for treating hypersensitivity reactions should be available for immediate use. If an anaphylactic or other serious allergic reaction occurs, administration of intravenous or subcutaneous ORENCIA should be stopped immediately and permanently discontinued, with appropriate therapy instituted.

Infections: Serious infections, including sepsis and pneumonia, were reported in 3% and 1.9% of RA patients treated with intravenous ORENCIA and placebo, respectively. Some of these infections have been fatal. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy which, in addition to their underlying disease, could further predispose them to infection. Caution should be exercised in patients with a history of infection or underlying conditions which may predispose them to infections. Treatment with ORENCIA should be discontinued if a patient develops a serious infection. Patients should be screened for tuberculosis and viral hepatitis in accordance with published guidelines, and if positive, treated according to standard medical practice prior to therapy with ORENCIA.

Immunizations: Prior to initiating ORENCIA in pediatric and adult patients, update vaccinations in accordance with current vaccination guidelines. Live vaccines should not be given concurrently with ORENCIA or within 3 months after discontinuation. ORENCIA may blunt the effectiveness of some immunizations.

Use in Patients with Chronic Obstructive Pulmonary Disease (COPD): In Study V, adult COPD patients treated with ORENCIA for RA developed adverse events more frequently than those treated with placebo, including COPD exacerbations, cough, rhonchi, and dyspnea. In the study, 97% of COPD patients treated with ORENCIA developed adverse events versus 88% treated with placebo. Respiratory disorders occurred more frequently in patients treated with ORENCIA compared to those on placebo (43% vs 24%, respectively), including COPD exacerbation, cough, rhonchi, and dyspnea. A greater percentage of patients treated with ORENCIA developed a serious adverse event compared to those on placebo (27% vs 6%), including COPD exacerbation [3 of 37 patients (8%)] and pneumonia [1 of 37 patients (3%)]. Use of ORENCIA in patients with COPD should be undertaken with caution, and such patients monitored for worsening of their respiratory status.

Immunosuppression: In clinical trials in adult RA patients, a higher rate of infections was seen in ORENCIA-treated patients compared to placebo-treated patients. The impact of treatment with ORENCIA on the development and course of malignancies is not fully understood. There have been reports of malignancies, including skin cancer in patients receiving ORENCIA. Periodic skin examinations are recommended for all ORENCIA-treated patients, particularly those with risk factors for skin cancer.

Blood Glucose Testing: ORENCIA for intravenous administration contains maltose, which may result in falsely elevated blood glucose readings on the day of infusion when using blood glucose monitors with test strips utilizing glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ). Consider using monitors and advising patients to use monitors that do not react with maltose, such as those based on glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), glucose oxidase or glucose hexokinase test methods. ORENCIA for subcutaneous (SC) administration does not contain maltose; therefore, patients do not need to alter their glucose monitoring.

Pregnancy: There are no adequate and well-controlled studies of ORENCIA use in pregnant women and the data with ORENCIA use in pregnant women are insufficient to inform on drug-associated risk. A pregnancy registry has been established to monitor pregnancy outcomes in women exposed to ORENCIA during pregnancy. Healthcare professionals are encouraged to register patients by calling 1-877-311-8972.

Lactation: There is no information regarding the presence of abatacept in human milk, the effects on the breastfed infant, or the effects on milk production. However, abatacept was present in the milk of lactating rats dosed with abatacept.

Most Serious Adverse Reactions: Serious infections (3% ORENCIA vs 1.9% placebo) and malignancies (1.3% ORENCIA vs 1.1% placebo).

Malignancies: The overall frequency of malignancies was similar between adult RA patients treated with ORENCIA or placebo. However, more cases of lung cancer were observed in patients treated with ORENCIA (0.2%) than those on placebo (0%). A higher rate of lymphoma was seen compared to the general population; however, patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma. The potential role of ORENCIA in the development of malignancies in humans is unknown.

Most Frequent Adverse Events (≥10%): Headache, upper respiratory tract infection, nasopharyngitis, and nausea were the most commonly reported adverse events in the adult RA clinical studies. Other events reported in ≥5% of pJIA patients were diarrhea, cough, pyrexia, and abdominal pain. In general, the adverse events in pediatric pJIA and adult PsA patients were similar in frequency and type to those seen in adult RA patients.

Note concerning ORENCIA administration options: ORENCIA may be administered as an intravenous infusion only for patients 6 years of age and older. PJIA patients may self-inject with ORENCIA or the patient’s caregiver may administer ORENCIA if both the healthcare practitioner and the parent/legal guardian determines it is appropriate. The ability of pediatric patients to self-inject with the autoinjector has not been tested.

Please click here for Full Prescribing Information.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements.

Contacts

Bristol Myers Squibb

Media Inquiries:
media@bms.com

Arlene Melendez

Arlene.Melendez@bms.com

Investors:
Tim Power

609-252-7509

Timothy.Power@bms.com

Nina Goworek

908-673-9711

Nina.Goworek@bms.com

Read full story here

Categories
Business Technology

Majesco appoints insurance industry expert as Chief Technology Officer

Former Amazon Web Services and industry veteran brings cloud platform expertise and leadership to support Majesco SaaS platforms

MORRISTOWN, N.J. — (BUSINESS WIRE) — Majesco, a global leader of cloud insurance software solutions for insurance business transformation, today announced the hiring of Ravi Krishnan as Chief Technology Officer (CTO) to oversee the architectural and technical direction for all Majesco SaaS platforms.

Adding Ravi to the team will help Majesco lead the insurance industry in the pursuit to modernize and optimize today’s companies. In order to compete and grow, the industry will demand new levels of operational efficiency and effectiveness, holistic digital experiences, the ability to rapidly launch new products and adapt to new opportunities. The continued rapid adoption of SaaS and Cloud is pivotal for insurers to thrive in this new-age of insurance.

“I am tremendously impressed with Majesco’s vast portfolio of products for all lines of insurance,” said Ravi Krishnan. “My goal is to help Majesco accelerate the industry and customer’s digital transformation to achieve agility, speed and innovation in a rapidly changing marketplace. End-to-end innovation across the portfolio with robust cloud-native architecture and engineering will elevate Majesco solutions and meet rising market demands. I am thrilled to join the Majesco team and leverage all my experience to benefit the industry and Majesco customers.”

Previously, Ravi was Principal Solutions Leader for Worldwide Healthcare and Insurance at Amazon Web Services (AWS). Prior to AWS, he was the Chief Digital Officer for Innoveo, CIO and SVP, Digital Product Innovation at Woodruff Sawyer and held other executive positions with Kaiser Permanente, Verizon, Cognizant, GE Insurance and PwC. His background will provide Majesco with enhanced expertise to continue leading digital insurance transformation.

“Ravi’s breadth and depth of technical experience leading cloud and digital platforms made him a clear standout for us,” said Manish Shah, President and Chief Product Officer of Majesco. “As an early leader in cloud platform solutions for the L&A and Group and P&C industries, Ravi’s experience with AWS will provide new levels of insight to propel us to the next chapter of our product and cloud story. I am thrilled to welcome Ravi to the Majesco family and look forward to working with him as we continue our journey to the future of insurance.”

About Majesco

Majesco is the leading software partner to both the P&C and L&A insurance markets to modernize, optimize and innovate their businesses at speed and scale. Over 330 insurers, from greenfields, start-ups and MGAs to the largest insurers, reinsurers and brokers use Majesco’s next generation SaaS platform solutions of core, data and analytics, digital, distribution, absence management and a rich ecosystem marketplace of established and InsurTech partners to build the future of insurance.

Our technology, expertise and leadership help insurers innovate and connect to build the future of their business. With over 825 successful implementations and over 65% of our customers on Cloud with Majesco platform solutions, together we have an amazing track record of innovation and real-world results. For more details on Majesco, please visit www.majesco.com.

Contacts

Laura Tillotson

Director, Marketing Communications and Creative Services

+ 201 230 0752

Laura.Tillotson@majesco.com

Categories
Business

AM Best announces availability of 2020 annual insurer financial data in Best’s Capital Adequacy Ratio Model – P/C, US

OLDWICK, N.J. — (BUSINESS WIRE) — AM Best has released its 2020 annual financial data from insurers that have completed their filings to date for Best’s Capital Adequacy Ratio (BCAR) Model – P/C, US.

The BCAR Model product allows customers to evaluate an insurer’s capitalization and risk profile using a model that is consistent with the methodology used by AM Best analysts, to capture the combined impact of financial risks associated with adverse market conditions.

For more information, visit our website or contact Business Development at +1 908 439 2200, ext. 5311, or sales@ambest.com.

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

Copyright © 2021 by A.M. Best Company, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Corporate Sales
+1 908 439 2200, ext. 5311
sales@ambest.com